Device brand name · Staple implantable
Unknown Endo Stitch SULU: medical device reports filed with FDA
247 reports name it, 2015–2026. Manufacturer given most often on reports: Davis & Geck Caribe. Product code GDW.
- 247
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 17
- reports, 12 months to August 2026
- 30 in the 12 months before
- 73.7%
- classified as malfunction
- 80.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
247 medical device reports received by FDA name the brand "Unknown Endo Stitch SULU" (staple implantable); the manufacturer given most often on reports is Davis & Geck Caribe; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
17 reports arrived in the 12 months to August 2026, down 43% from 30 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (73.7%) and injury (26.3%); across all staple, implantable reports (product code GDW) death is recorded in 0.6% and malfunction in 80.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (55.9%), break (32.8%) and human-device interface problem (25.1%). The patient problems coded most often are foreign body in patient, unintended radiation exposure and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 170,752 reports carrying product code GDW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 138 | 55.9% | 2.4% |
| Breakthe device broke | 81 | 32.8% | 4.9% |
| Human-device interface problem | 62 | 25.1% | 2.4% |
| Component or accessory incompatibility | 44 | 17.8% | 0.7% |
| Difficult to open or close | 6 | 2.4% | 9.7% |
| Insufficient device problem information | 6 | 2.4% | 2.9% |
| Material twisted/bent | 5 | 2% | 0.3% |
| Entrapment of device | 4 | 1.6% | 3.2% |
| Mechanical jam | 4 | 1.6% | 2.3% |
| Misfire | 2 | 0.8% | 9.1% |
| Component missing | 1 | 0.4% | 0.3% |
| Device difficult to setup or prepare | 1 | 0.4% | 0.4% |
| Difficult to insertthe device was hard to insert | 1 | 0.4% | 0.2% |
| Failure to align | 1 | 0.4% | 0.3% |
| Migration or expulsion of device | 1 | 0.4% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.4% | 0.1% |
| Unraveled material | 1 | 0.4% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 30 | 12.1% |
| Unintended radiation exposure | 19 | 7.7% |
| Device embedded in tissue or plaque | 11 | 4.5% |
| Radiation exposure, unintended | 6 | 2.4% |
| Tissue breakdown | 3 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.8% |
| Hemorrhage/blood loss/bleeding | 2 | 0.8% |
| Laceration(s) | 2 | 0.8% |
| Abdominal distention | 1 | 0.4% |
| Abdominal painstomach or belly pain | 1 | 0.4% |
| Hernia | 1 | 0.4% |
| Internal organ perforation | 1 | 0.4% |
| No patient involvement | 1 | 0.4% |
| Obstruction/occlusion | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Endo Stitch SULU | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 247 | 170,752 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 26.3% | 18.7% | 36.2% |
| Classified as malfunction | 73.7% | 80.3% | 62.3% |
| Filed by the manufacturer | 97.6% | 97% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code GDW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endo GIA | 30,619 | 2,086 | 0.3% |
| Endo GIA Ultra | 17,281 | 1,116 | 0.1% |
| Signia | 9,434 | 1,130 | 0.1% |
| Tri-Staple 2.0 | 5,267 | 661 | 0.3% |
| Gia | 4,899 | 404 | 0.9% |
| Eea | 4,922 | 542 | 0.8% |
| Powered 60 Echelon + 340mm Shaft | 3,237 | 224 | 0.4% |
| Ets Flex Articng Lnr Cutr 45mm | 2,512 | 79 | 0.3% |
| Unknown Endo GIA SULU | 2,408 | 205 | 1.9% |
| SureForm | 2,927 | 654 | 1.2% |
| Contour Curved Cutter Stapler | 1,961 | 11 | 0.3% |
| Ils 29mm Curved | 1,945 | 48 | 0.9% |
| Powered 60 Echelon + 440mm Shaft | 1,775 | 49 | 0.4% |
| Echelon Flex Powered Vascular Stapler With Advanced Placement Tip | 1,770 | 180 | 1.6% |
| 75mm Selectable New Tlc | 1,603 | 57 | 1.1% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Unknown Endo Stitch SULU reports
How many FDA reports name Unknown Endo Stitch SULU?
247 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 17 in the latest 12 months.
What kinds of events are reported?
malfunction (73.7%) and injury (26.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (55.9%), break (32.8%), human-device interface problem (25.1%), component or accessory incompatibility (17.8%) and difficult to open or close (2.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Endo Stitch SULU was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.